The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Sigvotatug vedotin is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Argentina, Australia, Belgium, Bulgaria, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Slovakia, South Korea, Spain, Taiwan
EXPERIMENTAL: Sigvotatug Vedotin with Pembrolizumab
Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
DRUG: Sigvotatug Vedotin
MMAE-Antibody Drug Conjugate targeting Integrin Beta-6DRUG: Pembrolizumab
Anti-PD-(L)1ACTIVE_COMPARATOR: Pembrolizumab Monotherapy
Participants will receive pembrolizumab, administered as an IV infusion.
DRUG: Pembrolizumab
Anti-PD-(L)1Overall Survival
Overall survival defined as the duration from enrollment to death.
Baseline to date of death from any cause (Approximately 2 years)
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
From Baseline to to date of first documentation of progression OR death (Approximately 2 year)
Progression Free Survival as assessed by Investigator
Progression Free Survival (PFS) is defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurs first.
From Baseline to date of first progression or death (Approximately 4 Years)
Objective Response Rate as assessed by BICR
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
From Baseline to to the date of progression OR death (approximately to 4 years)
Objective Response Rate as assessed by Investigator
defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
From Baseline to to the date of progression OR death (approximately to 4 years)
Duration of Response as assessed by BICR
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
Duration of Response as assessed by Investigator
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
Number of participants with adverse events (AEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
From Baseline to end of treatment (up to 4 years)
Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
PK of ac-MMAE in plasma: Plasma predose concentration (Cpredose)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
PK of unconjugated monomethyl auristatin E (MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
PK of MMAE in plasma: Plasma predose concentration (Cpredose)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
Number of participants with antidrug antibodies (ADAs)
To characterize the immunogenicity of sigvotatug vedotin when administered in combination with pembrolizumab
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
714
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06758401
Back
